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Processa Pharmaceuticals Announces Successful Completion of Phase 1b Safety Evaluation of NGC-Cap in Patients with Advanced Cancer Resulting in Recommended Phase 2 Doses
Next Generation Capecitabine (NGC-Cap) provides patients with 2-10 times greater exposure to its 5-FU cancer treatment metabolite than capecitabine
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Next Generation Capecitabine (NGC-Cap) provides patients with 2-10 times greater exposure to its 5-FU cancer treatment metabolite than capecitabine administration NGC-Cap was better tolerated with positive preliminary efficacy results than FDA-approved capecitabine HANOVER, MD, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces the successful completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine (“NGC-Cap”). From the Phase 1b data, two dosage regimens have been selected for the Phase 2 trial. The Phase 2 trial will be in advanced or metastatic breast cancer given FDA’s agreement that the Phase 1b data can be used to support the design of the Phase 2 trial in breast cancer. NGC-Cap is PCS6422 administered in combination with capecitabine, a precursor of the cancer drug 5-FU. PCS6422 is administered as a single dose 12-24 hours prior to receiving seven days of capecitabine followed by seven drug-free days. The NGC-Cap Phase 1b trial evaluated capecitabine doses from 75 mg once a day (QD) to 225 mg twice a day (BID). The 5-FU drug exposure for the 18 total patients that received NGC-Cap treatment across four different dosing regimens was 2-10 times that of FDA-approved capecitabine. Sixteen of these patients received at least two cycles of NGC-Cap with the other two patients discontinuing treatment before completing two cycles because of progressing disease. Four of the 16 patients are still receiving treatment in the study. At this time, only one of the 16 patients (6%) has experienced a mild case of hand-foot-syndrome (HFS), a side effect associated with the 5-FU metabolite fluoro-beta-alanine (FBAL). This lower incidence of HFS was expected given PCS6422 inhibits the metabolism of 5-FU to FBAL. The 6% incidence of HFS differs from the incidence reported for FDA-approved capecitabine, where greater than 50% of patients on capecitabine developed HFS and greater than 10% of the patients developed severe HFS. The incidence of myelosuppression in patients on the high dose of NGC-Cap (225 mg BID) is currently approximately 71%, with more...